Melanoma Metastasized to the Brain and Steroids

Recruiting Phase 2 Interventional Study
Malignant Melanoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Inge Marie Svane · Other
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About This Trial
This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\> 10 \< 25 mg prednisolone or \> 25 mg prednisolone) and treatm…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically confirmed metastatic melanoma with radiologically verified brain metastasis * Need for systemic steroid treatment (prednisolone \> 10 mg daily; dexamethasone \> 1.6 mg daily, hydrocortisone \> 40 mg daily or equivalent) due to brain metastasis * At least one mea…
Contacts

Inge M Svane, Professor

004538683868

inge.marie.svane@regionh.dk

CONTACT

Troels H Borch, PhD

004538683868

troels.holz.borch@regionh.dk

CONTACT